LEADER MEDICATED WIPE  - witch hazel solution 
CARDINAL HEALTH

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient                                                                       Purpose

Witch Hazel, 50% v/v................................................................Astringent

Uses

For temporary relief of local discomfort itching, burning, and irritation associated with hemorrhoids

For external use only.  Avoid contact with eyes.

Consult a doctor

Do not put this product into rectum using fingers or any mechanical device or applicator

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and older, up to 6 times daily or after each bowel movement

Children under 12, consult a doctor

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product

Gently apply to the affected area by patting and discard

Apply to the affected area up to 6 times daily or after each bowel movement

Other information

Store at room temperature: 15o-30oC (59o-86oF)

Inactive ingredients

aloe barbadensis gel, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 4246294

www.myleader.com

1-800-200-6313

Made in China

image of carton label

LEADER MEDICATED WIPE  
witch hazel solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-741
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 5 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-741-67 48 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 03/01/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 3/2012
Document Id: 3bef5f79-1f57-4492-89df-71d1aead8fbb
Set id: 7cc16245-e295-47e2-ad14-eaa827bb703e
Version: 3
Effective Time: 20120301
 
CARDINAL HEALTH